Wednesday, August 26, 2015

Written by, Regulatory specialist, LMG, Published on 8-26-2015Compounding
is a preparation in which a licensed pharmacist or physician, or, in the case
of an outsourcing facility, a person under the guidance of a licensed
pharmacist, combines, mixes, or alters ingredients of a drug to create a
medication custom-made to the needs of an individual patient.

Compounded
drugs are not FDA-approved, FDA does not verify the safety, orefficiency of compounded drugs. State boards
of pharmacy will continue to have major responsibility for the day-to-day
oversight of state-licensed pharmacies that compound drugs in agreement with
the conditions of section 503A of the FDCA, although FDA retains some influence
over their operations. But, outsourcing facilities that register under section
503B are regulated by FDA and must fulfil the CGMP requirements and will be
inspected by FDA according to a risk-based schedule.

An
“outsourcing facility” is the place where they compound the sterile drugs.An
outsourcing facility can qualify for exceptions from the FDA approval
requirements and the condition to label products with adequate directions for
use, but not the exclusion from current good manufacturing practice (CGMP)
requirements.

Outsourcing facilities:

·Must comply with CGMP requirements;·Will be inspected by FDA according to
a risk-based schedule·Must meet certain other conditions,
such as reporting adverse events and providing FDA with certain information
about the products they compound.

If the
facilities engages compounding sterile human drugs they may register withFDA as an Outsourcing facility.

If the
facility engages in repacking human drugs, mixing, diluting or repacking
biological products, compounding non-sterile drugs and compounding animal drugs
do not need to register as an outsourcing facility since the drugs it produce
will not be eligible for the exemptions as in 503B of FD&C Act.

Liberty Management Group LTD, one of the leading FDA consulting group in the USA, can assist you with register your facility with FDA, LMG will help you with SPL preparation and submission to FDA, Drug establishment registration, drug listing and provide US Agent service to foreign facilities.

Certificate of Free sale, which is also known as FDA Export Certificate is a document which certifies that the product manufactured in US is eligible for export. This certificate states that there are no overheads or pending impulsive actions on the manufacturer. This is a document which contains information about a product’s regulatory and marketing status.

This Certificate of free sale or export certificate is needed by many foreign governments because they want to ensure that the products marketed in their country comply with US FDA regulations. This is issued by the FDA upon request by the manufacturer which meet the FDA regulations.

The certificate of free sale is for food including dietary supplements and cosmetics. FDA export certificate is for human drugs, animal drugs and medical devices that meet up with the FDA standards and the manufacturers should follow the cGMP.

FDA will not issue the Certificate of free sale or export certificate, if the product is not exported from US. Manufacturers has to register their facility with FDA before they apply for the Certificate of free sale from FDA.

Liberty Management Group Ltd, US based leading FDA Consulting group can guide you through the export certificate request process, which will help you to get the process easier. LMG also provide assistance with facility registration with FDA.

written by : FDA Registration Specialist, LMG
Published on : 6-16-2015